Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery

NCT ID: NCT01049724

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 196 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2017-11-30

Brief Summary

The purpose of this study is to measure tear lacritin and heparanase levels before and following surgery using a minimal risk procedure to collect tears from patients undergoing PRK or LASIK.

Detailed Description

Lacritin is a naturally occurring tear protein with antimicrobial activity that is capable of stimulating mitogenesis in human corneal epithelial cells and promoting production of tears in lacrimal gland acinar cells. A recently developed immunoassay for lacritin may help characterize the lacritin response following refractive surgery with the possible development of recombinant lacritin as a novel therapeutic agent for wound healing. Heparanase (HPSE) acts as a regulator for lacritin by cleaving heparan sulfate chains and allowing lacritin to bind. We aim to measure both tear lacritin and HPSE pre- and post-operatively to elucidate lacritin and HPSE's response in patients undergoing PRK (photorefractive keratectomy) and LASIK (Laser-assisted in situ keratomileusis) at the Walter Reed Center for Refractive Surgery.

Conditions

Myopia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PRK

Those patients undergoing photorefractive keratectomy

Tear collection

Intervention Type: OTHER

Tear collection

LASIK

Those undergoing Laser-assisted insitu keratomileusis

Tear collection

Intervention Type: OTHER

Tear collection

Interventions

Tear collection

Tear collection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Active duty US Army Soldiers eligible for care at FBCH
• Undergoing PRK or LASIK
• Male or female, of any race, and at least 21 years old and not older than 55 years old at the time of the tear collection. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
• Appropriately aged individuals who report that their eyes are "normal" and who have no active eye illness as determined by the principal investigator or sub-investigator.
• Ability and willingness to understand and provide informed consent to participate in this study.
• Up to -10.00 diopters of myopia.
• Subject must expect to be located in the greater Washington DC area for a 12 month period post-operatively.
• Consent of the subject's command (active duty) to participate in the study.
• Access to transportation to meet follow-up requirements.

Exclusion Criteria

• Any reason to be excluded for PRK or LASIK
• Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not]
• Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
• Any physical or mental impairment that would preclude participation in any of the examinations.
• Anterior basement membrane dystrophy
• History of recurrent epithelial erosion
• Significant dry eye (symptomatic with Schirmer <5mm at 5 minutes)
• Other corneal epithelial disorder or healing abnormality
• Individuals with any infectious or inflammatory ocular conditions (e.g. have "pink eye" or uveitis).
• Individuals diagnosed with dry eye or other ocular surface condition, including but not restricted to neurotropic keratitis, anterior basement membrane dystrophy, and recurrent corneal erosions.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

James Madison University

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: collaborator

Fort Belvoir Community Hospital

FED

Sponsor Role: lead

Responsible Party

COL Bruce Rivers

Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kraig S. Bower, MD

Role: PRINCIPAL_INVESTIGATOR

The Wilmer Eye Institute, Johns Hopkins University

Locations

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, United States

Countries

United States

Other Identifiers

351515

Identifier Type: -

Identifier Source: org_study_id